General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT06246916

Background Information

The purpose of this research is to investigate the safety and effectiveness of the combination of fianlimab and cemiplimab as compared with the combination of two medications, relatlimab and nivolumab, commercialized under the brand name Opdualag™ for treating melanoma. 

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
Principal Investigator

Jafar Al-Mondhiry, MD

Eligibility Information

  • Age ≥18 years on the date of providing informed consent
  • Participants with histologically confirmed unresectable stage III and stage IV (metastatic) 
    melanoma per AJCC, eighth revised edition
  • Participants must not have received prior systemic therapy for unresectable or metastatic 
    melanoma
  • Measurable disease per RECIST version 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1
  • Adequate bone marrow function
  • Adequate hepatic function
  • Adequate kidney function

Ineligibility Information

  • Uveal, acral or mucosal melanoma.
  • Ongoing or recent (within 2 years) evidence of an autoimmune disease that required 
    systemic treatment with immunosuppressive agents. The following are non-exclusionary: 
    vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.
  • Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection. Mild cancer-related immunodeficiency (such as 
    immunodeficiency treated with gamma globulin and without chronic or recurrent infection) is allowed.
  • Another primary malignancy that is progressing or required active treatment in the past 
    2 years, except for those with a negligible risk of metastasis or death (such as adequately 
    treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized 
    prostate cancer, or ductal carcinoma in situ). Adjuvant hormonotherapy used for breast 
    cancer or other hormone-sensitive cancers in long-term remission is allowed.
  • Pregnant or breastfeeding. 
  • Continued sexual activity in WOCBP or sexually active men who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose